FDA EIR - Llorens Pharmaceuticals International Division, Inc. - March 11, 2020

Llorens Pharmaceutical International Division, Inc. (LPI) underwent a comprehensive FDA surveillance inspection from March 3-11, 2020. Conducted under current Good Manufacturing Practices (cGMP) for over-the-counter (OTC) drugs and dietary supplements, the inspection covered quality, materials, production, and laboratory control systems as per compliance program 7356.002.The FDA issued a Form 483 detailing several deficiencies. Main observations included inadequate adherence to written Quality Control Unit (QCU) responsibilities, specifically a lack of procedures for chromatogram evaluation and inconsistent implementation of QC standard operating procedures and test methods. Investigators also found unclean laboratory glassware, insufficient evaluation of test method suitability, and an unprotected HPLC computer clock and calendar. Additionally, filling batch records for Tusnel Pediatric lacked complete in-process control results. Critical issues identified included the company’s failure to adequately investigate out-of-specification purified water test results, such as a high Total Plate Count and the detection of Burkholderia cepacia complex. Verbal discussions also addressed concerns like inappropriate balance calibration weight bracketing, inadequate instructions for reporting adverse events to the FDA in complaint procedures, and insufficient documentation and marking for the purified water system.LPI’s CEO committed to rectifying these violations and providing a written response to the FDA within 15 business days, outlining corrective actions.